When it comes to medications, the Food and Drug Administration (FDA) sets strict standards for consumer safety.
However, patients may unknowingly take defective drugs with dangerous side effects. Who is at fault if a drug causes serious or even fatal results?
The FDA issues guidelines for consumer safety with respect to various kinds of medication. However, the process associated with drug approval is slow-moving and can take years. Still, defective drugs do make it to market and can cause harm. Doctors may prescribe a drug that does not interact well with other medications a patient is taking.
Before going to market, new drugs must pass three rounds of tests using human subjects. However, these clinical trials generally involve only small groups of people and serious side effects may not show up. In fact, troubling side effects may not appear for years after a drug is released to the public. The Journal of the American Medical Association released a 2017 study showing that almost one-third of the drugs the FDA approved between 2001 through 2010 had unidentified side effects once they were available to consumers. If the risks outweigh the benefits, the FDA may order a recall. Top reasons for recall include contamination, adverse reaction and mislabeling.
An in-depth investigation is the first step in determining fault if a patient suffers a severe reaction such as nerve damage, brain damage or even death. The fault may lie with the drug manufacturer, the pharmacy that sold the medication or with the nurse who administered the drug. In addition, a physician may face a charge of medical malpractice when a patient has an adverse reaction due to the medication the doctor prescribed.